TRansmural hEaliNg Definition in CroHn's Disease (TRENCH 1)

ClinicalTrials.gov ID

NCT05903066

Lead Sponsor

Groupe d'Etude Therapeutique des Affections Inflammatoires DigestivesOTHER

Overall Status

Recruiting

Study Type

Observational

Enrollment

210Estimated

Last Update Posted

Oct 8, 2024Actual

Start Date

Sep 28, 2023Actual

Primary Completion Date

Jul 2025Estimated

Completion Date

Aug 2025Estimated

Official Title

TRansmural hEaliNg Definition in CroHn's Disease - The TRENCH1 Study

Brief Summary

Multicenter prospective cross-sectional study of CD patients, its aim is the construction of an objective and reproducible system for evaluation of Transmural healing in Crohn's Disease (CD).

Primary objective : Objective definition of depth or grade of transmural healing in relation to radiologic signs observed during Magnetic Resonance Enterography (MRE) in CD

Detailed Description

Number of patients : 210 patients, in 14 sites (only one investigator per site), 15 patients per site, 5 patients per grade of transmural healing based on the appraisal of a local reader pair (a gastroenterologist and a radiologist).

Recruitment period : 2 years

Primary Endpoint : Objective definition of depth or grade of transmural healing in relation to radiologic signs observed during Magnetic Resonance Enterography (MRE) in CD

Secondary Endpoints :

• To analyze intra- and inter-observer variability of radiological findings.
• To analyze intra- and inter-observer variability of TH definitions in CD.

• Crohn Disease

• Magnetic Resonance Enterography (MRE)

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• ≥ 18 years of age
• Patient diagnosed with CD for more than 6 months with histological confirmation available in his medical record.
• Indication for MRE based on routine clinical practice validated by the treating physician
• Any CD treatment will be authorized, such as biologicals (infliximab, adalimumab, vedolizumab, ustekinumab…), or immunomodulators (azathioprine, 6-mercaptopurine, methotrexate…).
• The subjects sign and date a written, informed consent form and any required privacy authorization prior to the initiation of the study.
• A subject can be enrolled into the study only if the grade of TH (assessed by the LRP) corresponding to the subject is not already fulfilled.

Exclusion Criteria:

• Pregnancy during the study
• People unable to give consent (because of their physical or mental state)
• Absence of written consent
• Ulcerative colitis or unclassified IBD
• Specific postsurgical settings: ileoanal anastomosis, ileostomy or colostomy.
• Less than 3 evaluable ileocolic segments or more than 3 resected ileocolonic segments (not counting ileocecal valve)
• Severe obstructive symptoms
• Symptomatic intra-abdominal abscess
• Contraindication for MRI
• Isolated perianal disease without luminal location
• MRE images of poor quality, based on previously defined criteria

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Groupe d'Etude Therapeutique des Affections Inflammatoires DigestivesOTHER

fumery.mathurin@chu-amiens.fr

benoit.coffin@aphp.fr

sofia.hambli@chru-lille.fr

sophie.geyl@chu-limoges.fr

melanie.serrero@ap-hm.fr

catherine@leberre.org

hebuterne.x@chu-nice.fr

ludovic.caillo@chu-nimes.fr

stephane.nancey@chu-lyon.fr

guillaume.bouguen@chu-rennes.fr

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